Postoperative Nausea and VomitingPhase 4(PONV)NCT05071794
Effect of Propofol on Postoperative Nausea and Vomiting.
A Phase 4 study testing Propofol and saline 0.9% in people with Postoperative Nausea and Vomiting, run by Pakistan Air Force (PAF) Hospital Islamabad at 1 site in Pakistan.
Trial summary
As PONV is an unpleasant experience that badly affects the patients' quality of life after surgery and the anti-emetic effects of propofol have been seldomly studied in Pakistan, this study aims at investigation of the beneficial effects of propofol in reducing the occurrence of PONV. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Propofol and saline 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2021to 29 Oct 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Parturient aged between 18 - 50 years
- Elective Cesarean under spinal anesthesia
- Patients at increased risk of PONV based on Apfel score 2 or more
- ASA Class II
- Ability to give informed consent
Who cannot join
- Allergy to propofol
- ASA Class III and above
- Anti emetic drug administered 24 hrs prior to surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Propofol on Postoperative Nausea and Vomiting in Patients Undergoing Elective Cesarean Section Under Spinal Anesthesia.
As PONV is an unpleasant experience that badly affects the patients' quality of life after surgery and the anti-emetic effects of propofol have been seldomly studied in Pakistan, this study aims at investigation of the beneficial effects of propofol in reducing the occurrence of PONV.
Read the detailed description
Cesarean Section is one of the most commonly performed surgical procedures in the obstetric patients. Adequate intra and postoperative analgesia is very important in providing comfort to the mother, early breastfeeding, ambulation and discharge as well as enhancing patient satisfaction.Spinal anesthesia is widely accepted as the anesthesia of choice for cesarean section owing to its safety and speed. PONV is an unpleasant condition, often underestimated side effect of anesthesia and surgery, quite common in women undergoing spinal anesthesia for cesarean.It is one of the significant problems in Post Anaesthesia Care Units. The etiology of PONV is multifactorial with patient factors (gender, history of motion sickness, age), intra Op factors (type of anesthesia, surgery and opioid use) and post Op factors (pain, post Op opioid use) which are found to be associated with the PONV. Apfel simplified scoring is based on four independent factors including female gender, non-smoker, history of PONV or motion sickness and use of opioids. Each predictor is given a score of 1. A score of 0,1,2,3 or 4 predicts the chance of developing PONV as approximately 10%, 20%, 40% or 80%.
The intense efforts accompanying emesis increase the risk of complications such as wound dehiscence, bleeding, aspiration pneumonitis, dehydration, electrolyte imbalance and interference with nutrition. While it is difficult to completely avoid the occurrence of PONV, it can be markedly reduced using a multimodal non-opioid analgesia, total intravenous anesthesia and adequate prophylactic antiemetic premedication. Propofol has been reported to have anti-emetic effects at sub hypnotic dose as a bolus or a continuous infusion in susceptible individuals undergoing surgeries, though the exact mechanism of this effect is yet to be discovered.
In a research published in BMC Anesthesiology, the data indicates a significant difference in the incidence of PONV in control group (93.9%) and the study group (8.7%) with a single sub hypnotic dose of propofol administered 10-15 min before the end of surgery in parturients undergoing cesarean section under spinal anaesthesia.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Propofol, saline 0.9%
- Keywords
- postoperative nausea and vomiting, propofol
- Medical subject headings
- Postoperative Nausea and Vomiting, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called propofol injection
Antiemetic effect of propofol
saline 0.9%Drug
Also called normal saline
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Active comparator | Subhypnotic dose of propofol, 0.5mg/kg, 10 - 15 min before end of surgery Receives: Drug: Propofol |
| Placebo | Placebo comparator | Normal saline 0.9%, 10 mL , 10 - 15 min before end of surgery Receives: Drug: saline 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative nausea and vomiting
Subjective complaint of nausea or any episode of vomiting
Measured: 1 hour stay in Postanaesthesia Care Unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start1 May 2021
- Primary completion29 Oct 2021
- Study completion29 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Air Force (PAF) Hospital Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atif Nazir, Pakistan Air Force (PAF) Hospital Islamabad
- Investigators
- ATIF NAZIR, MD, Principal investigator, PAF Hospital Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071794
- Sponsor's protocol ID
- PAFHIslamabad
- Acronym
- (PONV)
- Status last verified
- Jan 2023
- First submitted
- 28 Sep 2021
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Niu K, Liu H, Chen RW, Fang QW, Wen H, Guo SM, Williams JP, An JX. Use of propofol for prevention of post-delivery nausea during cesarean section: a double-blind, randomized, placebo-controlled trial. J Anesth. 2018 Oct;32(5):748-755. doi: 10.1007/s00540-018-2549-x. Epub 2018 Sep 12.
PubMed 30209576Shaikh SI, Nagarekha D, Hegade G, Marutheesh M. Postoperative nausea and vomiting: A simple yet complex problem. Anesth Essays Res. 2016 Sep-Dec;10(3):388-396. doi: 10.4103/0259-1162.179310.
PubMed 27746521Urits I, Orhurhu V, Jones MR, Adamian L, Borchart M, Galasso A, Viswanath O. Postoperative Nausea and Vomiting in Paediatric Anaesthesia. Turk J Anaesthesiol Reanim. 2020 Apr;48(2):88-95. doi: 10.5152/TJAR.2019.67503. Epub 2019 Nov 11.
PubMed 32259138Kim EG, Park HJ, Kang H, Choi J, Lee HJ. Antiemetic effect of propofol administered at the end of surgery in laparoscopic assisted vaginal hysterectomy. Korean J Anesthesiol. 2014 Mar;66(3):210-5. doi: 10.4097/kjae.2014.66.3.210. Epub 2014 Mar 28.
PubMed 24729843Jelting Y, Klein C, Harlander T, Eberhart L, Roewer N, Kranke P. Preventing nausea and vomiting in women undergoing regional anesthesia for cesarean section: challenges and solutions. Local Reg Anesth. 2017 Aug 9;10:83-90. doi: 10.2147/LRA.S111459. eCollection 2017.
PubMed 28860857Kampo S, Afful AP, Mohammed S, Ntim M, Buunaaim ADB, Anabah TW. Sub-hypnotic dose of propofol as antiemetic prophylaxis attenuates intrathecal morphine-induced postoperative nausea and vomiting, and pruritus in parturient undergoing cesarean section - a randomized control trial. BMC Anesthesiol. 2019 Sep 14;19(1):177. doi: 10.1186/s12871-019-0847-y.
PubMed 31521119
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Propofol on Postoperative Nausea and Vomiting in Patients Undergoing Elective Cesarean Section Under Spinal Anesthesia.
- ClinicalTrials.gov ID
- NCT05071794
- Acronym / sponsor ID
- (PONV) / PAFHIslamabad
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- postoperative nausea and vomiting, propofol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pakistan Air Force (PAF) Hospital IslamabadUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 29 Oct 2022 (actual)
- First posted
- 8 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As PONV is an unpleasant experience that badly affects the patients' quality of life after surgery and the anti-emetic effects of propofol have been seldomly studied in Pakistan, this study aims at investigation of the beneficial effects of propofol in reducing the occurrence of PONV.
Detailed description
Cesarean Section is one of the most commonly performed surgical procedures in the obstetric patients. Adequate intra and postoperative analgesia is very important in providing comfort to the mother, early breastfeeding, ambulation and discharge as well as enhancing patient satisfaction.Spinal anesthesia is widely accepted as the anesthesia of choice for cesarean section owing to its safety and speed. PONV is an unpleasant condition, often underestimated side effect of anesthesia and surgery, quite common in women undergoing spinal anesthesia for cesarean.It is one of the significant problems in Post Anaesthesia Care Units. The etiology of PONV is multifactorial with patient factors (gender, history of motion sickness, age), intra Op factors (type of anesthesia, surgery and opioid use) and post Op factors (pain, post Op opioid use) which are found to be associated with the PONV. Apfel simplified scoring is based on four independent factors including female gender, non-smoker, history of PONV or motion sickness and use of opioids. Each predictor is given a score of 1. A score of 0,1,2,3 or 4 predicts the chance of developing PONV as approximately 10%, 20%, 40% or 80%.
The intense efforts accompanying emesis increase the risk of complications such as wound dehiscence, bleeding, aspiration pneumonitis, dehydration, electrolyte imbalance and interference with nutrition. While it is difficult to completely avoid the occurrence of PONV, it can be markedly reduced using a multimodal non-opioid analgesia, total intravenous anesthesia and adequate prophylactic antiemetic premedication. Propofol has been reported to have anti-emetic effects at sub hypnotic dose as a bolus or a continuous infusion in susceptible individuals undergoing surgeries, though the exact mechanism of this effect is yet to be discovered.
In a research published in BMC Anesthesiology, the data indicates a significant difference in the incidence of PONV in control group (93.9%) and the study group (8.7%) with a single sub hypnotic dose of propofol administered 10-15 min before the end of surgery in parturients undergoing cesarean section under spinal anaesthesia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Drug: PropofolSubhypnotic dose of propofol, 0.5mg/kg, 10 - 15 min before end of surgery |
| Placebo | Placebo comparator | Drug: saline 0.9%Normal saline 0.9%, 10 mL , 10 - 15 min before end of surgery |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Parturient aged between 18 - 50 years
- Elective Cesarean under spinal anesthesia
- Patients at increased risk of PONV based on Apfel score 2 or more
- ASA Class II
- Ability to give informed consent
Key exclusion criteria (3 listed)
- Allergy to propofol
- ASA Class III and above
- Anti emetic drug administered 24 hrs prior to surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolAlso: propofol injectionAntiemetic effect of propofol | Drug | Propofol |
| saline 0.9%Also: normal salinePlacebo | Drug | Placebo |
Primary outcome
postoperative nausea and vomiting
Time frame: 1 hour stay in Postanaesthesia Care Unit
Subjective complaint of nausea or any episode of vomiting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Background: PubMed 30209576Niu K, Liu H, Chen RW, Fang QW, Wen H, Guo SM, Williams JP, An JX. Use of propofol for prevention of post-delivery nausea during cesarean section: a double-blind, randomized, placebo-controlled trial. J Anesth. 2018 Oct;32(5):748-755. doi: 10.1007/s00540-018-2549-x. Epub 2018 Sep 12.
- Background: PubMed 27746521Shaikh SI, Nagarekha D, Hegade G, Marutheesh M. Postoperative nausea and vomiting: A simple yet complex problem. Anesth Essays Res. 2016 Sep-Dec;10(3):388-396. doi: 10.4103/0259-1162.179310.
- Background: PubMed 32259138Urits I, Orhurhu V, Jones MR, Adamian L, Borchart M, Galasso A, Viswanath O. Postoperative Nausea and Vomiting in Paediatric Anaesthesia. Turk J Anaesthesiol Reanim. 2020 Apr;48(2):88-95. doi: 10.5152/TJAR.2019.67503. Epub 2019 Nov 11.
- Background: PubMed 24729843Kim EG, Park HJ, Kang H, Choi J, Lee HJ. Antiemetic effect of propofol administered at the end of surgery in laparoscopic assisted vaginal hysterectomy. Korean J Anesthesiol. 2014 Mar;66(3):210-5. doi: 10.4097/kjae.2014.66.3.210. Epub 2014 Mar 28.
- Background: PubMed 28860857Jelting Y, Klein C, Harlander T, Eberhart L, Roewer N, Kranke P. Preventing nausea and vomiting in women undergoing regional anesthesia for cesarean section: challenges and solutions. Local Reg Anesth. 2017 Aug 9;10:83-90. doi: 10.2147/LRA.S111459. eCollection 2017.
- Results publication: PubMed 31521119Kampo S, Afful AP, Mohammed S, Ntim M, Buunaaim ADB, Anabah TW. Sub-hypnotic dose of propofol as antiemetic prophylaxis attenuates intrathecal morphine-induced postoperative nausea and vomiting, and pruritus in parturient undergoing cesarean section - a randomized control trial. BMC Anesthesiol. 2019 Sep 14;19(1):177. doi: 10.1186/s12871-019-0847-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ATIF NAZIR, MD principal investigator
PAF Hospital Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol and saline 0.9% in people with Postoperative Nausea and Vomiting, run by Pakistan Air Force (PAF) Hospital Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative nausea and vomiting (time frame: 1 hour stay in Postanaesthesia Care Unit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05071794, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.